Affymax, Inc. - Careers: Associate Director, QC Methods Transfer

Position Purpose

Lead method transfer process effectively to deliver analytical methods from one department to another and/or from one site to another. Coordinate validation activities for release, stability and in-process methods to support the manufacture of product suitable for FDA licensure. Report to Senior Director, Quality Control.

Principal Duties and Responsibilities

Supervise activities of laboratory personnel to successfully complete method transfers from the Analytical Development Department to the Quality Control Department.
Lead method transfers and validation activities between Affymax QC and multiple sites (Contract Testing Laboratories [CTLs], Contract Manufacturing Operations and API Manufacturing sites). Recommend revalidation when appropriate.
Act as liaison between QC and Analytical Development to insure methods are implemented according to timelines. Resolve issues that may arise in parallel projects and ensure effective cross-functional communication.
Establish a GMP laboratory; qualify laboratory equipment including writing instrument protocols. Identify outsourced resources required for these activities.
Write, review, and/or approve test method SOPs, method development reports, qualification and validation reports generated in Affymax Analytical Development Department and CTLs.
Evaluate analytical methods and improve their ruggedness so that they can be conducted at CTLs and API sites. Recommend additional methods for determining degradants and impurities observed in the stability program.
Provide quality control assistance to Contract Manufacturers as requested including microbial and analytical testing of raw materials used to manufacture Affymax products. Lead the identification and problem-solving of product related investigations and/or process related issues occurring at the API sites.
Create a budget including reagents, materials and equipment needed for method transfers. Hire, train, and provide career development to department personnel. Manage and coordinate the activities of personnel in all sampling and testing activities.
Prepare and/or assist in writing regulatory submissions (IND, NDA).

Qualifications

Master's degree in Analytical Chemistry, Biochemistry, Protein Sciences or related field.
10 years of progressive responsibility in a GMP environment and at least 5 years managing a QC function.
Extensive expertise in a variety of analytical techniques including HPLC, electrophoresis, bio-assays and spectroscopy to determine the purity and impurity profiles of peptides and/ or proteins.
Hands-on experience with method development, validation and transfer in support of pharmaceutical manufacturing.
Strong supervisory and project leadership skills and experience managing contract testing labs.
Excellent written and oral communications skills.
Experience interacting with representatives of Regulatory agencies for pre-approval inspections.

Affymax, Inc.
Human Resources
4001 Miranda Avenue
Palo Alto, CA 94304
careers@affymax.com